The Animal Health Summer School

The development of a veterinary medicine is complex, time consuming and expensive. It requires teamwork from individuals with different scientific training and a wide range of skills. Everyone involved must be aware of the main stages in the development programme and be able to relate his or her responsibilities to the expertise and needs of the scientists and commercial members of the team. Furthermore, different approaches taken by the regulatory authorities in the European Union and the USA, mean that a comprehensive development programme must be designed in order for the product to be commercialised in both the American and European regions.

This course has been designed to demonstrate how pharmaceutical, pharmacological, toxicological and clinical investigations and regulatory management are brought together in the development programme. It will take the participants through the stages in the development of a veterinary medicinal product for which a marketing authorisation is sought in the European Union and the USA. Presentations will cover; pharmaceutical and process development, toxicological, pharmacological, residues and ecotoxicological studies, safety risk assessments, clinical development, pharmacovigilance, regulatory and marketing input and project management.

An important part of the course will be devoted to working on case studies in the workshop sessions. The course will provide a comprehensive introduction to the entire development programme.


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